Wheeled Mobility for Preventing Pressure Ulcers (RCT-WC2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01275313

Recruitment Status
:
Completed

First Posted
: January 12, 2011

Results First Posted
: June 9, 2017

Last Update Posted
: June 9, 2017

Sponsor:

University of Pittsburgh

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.

Condition or disease

Intervention/treatment

Mobility Limitation

Device: Lightweight wheelchairDevice: Skin Protection Cushion

Detailed Description:

Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

60 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female nursing home resident 60 years of age and older

A Braden score of less than or equal to 18

A combined Braden Activity and Mobility Subscale score less than or equal to 5

Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer)

A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous)

Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4)